NCT05200260RecruitingPhase 2
Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 10 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 17 Jan 2022
- Start date
- 13 Jul 2022
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Shanghai Gynecologic Oncology Group
- Diseases
- Ovarian cancer
- NCT number
- NCT05200260
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 220
- From 13 Jul 2022 to the primary completion date, 30 Jun 2027
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise adherence to the protocol.
Other illness
- Non-epithelial ovarian malignancies and borderline tumors
- Low grade ovarian cancer
- Mucinous ovarian cancer
- Patient has a known hypersensitivity to the components of olaparib/bevacizumab or its excipients
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, thyroid carcinoma, or breast carcinoma (without any signs of relapse or activity, early-stage).
- Other conditions, such as religious, psychological, and other factors, that could interfere with the provision of informed consent, compliance to study procedures, or follow-up.
Other
- Complete cytoreduction cannot be achieved according to preoperative evaluation, including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases
Who the study is looking for
- Females aged ≥ 18 years.
- Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma
- Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET/CT examination
- Complete cytoreduction can be achieved based on CT or PET/CT examination
- Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing
- Performance status (ECOG 0-2)
- Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:
- white blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
- serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,
- serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL.
- Comply with the study protocol and follow-up.
- Patients who have given their written informed consent.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First People's Hospital of Foshan Coordinator of this site? Confirm its status | Foshan | China | Recruiting |
| Sun Yet-Sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital of University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Obstetrics and Gynecology Hospital of Fundan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Fudan University Cancer hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.